Kornimate/medical-research-clean huggingface dataset:
effects of low tidal volume and airway pressure release ventilation on lung tissue mechanics in ards patients under mechanical ventilation: a prospective randomized crossover study

Conditions: ARDS (Acute Respiratory Distress Syndrome)

Summary: the goal of this clinical trial is to learn how low tidal volume ventilation (ltv) and airway pressure release ventilation (aprv) affect lung tissue mechanics in adults with ards. the main questions it aims to answer are: does ltv or aprv improve lung tissue mechanics in patients with ards under mechanical ventilation? researchers will compare ltv and aprv to see which ventilation mode works better for improving lung mechanics and patient safety.


Eligibility criteria:
inclusion criteria: 1. meets the diagnostic criteria of the 2023 global new definition of ards. 2. age: 18-80 years. 3. pao2/fio2 ≤ 200. 4. within 12 hours of invasive mechanical ventilation treatment. 5. obtain consent from the patient or their family members to participate in the study, and sign the informed consent form. exclusion criteria: 1. age \ 80 years. 2. uncorrected shock of any type. 3. chronic obstructive pulmonary disease (copd), pulmonary embolism, right heart failure, pulmonary hypertension, or severe arrhythmia. 4. contraindications for using electrical impedance tomography (eit) (extensive chest skin damage, infection, pacemaker implantation, implanted automatic defibrillator, etc.), pneumothorax, mediastinal emphysema, or large pleural effusion. 5. pregnant or breastfeeding women. 6. patients planned for ecmo treatment. 7. patients currently participating in or previously enrolled in other clinical studies.

Keywords: ards mp drrs
effect of insulin therapy by ultrasonography in wound healing of chronic diabetic patients

Conditions: Diabetes Mellitus

Summary: the main aim of the study is to determine the effect of transdermal application of insulin therapy by phonophoresis in wound healing in diabetic patients the main question of the study: is insulin phonophoresis is effective in accelerating healing in patients with diabetes mellites? 40 patients will be randomly assigned to two groups group a will receive insulin phonophoresis plus hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks. group b will receive hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks.

dimst scale ( as an acronym from the initial domains of depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining) will be used for assessment. manova will be used for statistical analysis between group comparison

Eligibility criteria:
inclusion criteria: * patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients. exclusion criteria: patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

Keywords: diabetes mellites, insulin phonophoresis
cognitive effects of bariatric surgery

Conditions: Bariatric Surgery Patients

Summary: there is growing evidence that obesity is associated with adverse neurocognitive outcome. recent studies demonstrate that elevated body mass index (bmi) is an independent risk factor for alzheimer's disease, structural brain abnormalities, and cognitive dysfunction in older adults. preliminary work from our lab extends these findings and shows structural brain differences and cognitive dysfunction also exist in obese young and middle-aged adults. bariatric surgery is increasingly viewed as an effective intervention for morbid obesity, though its effects on cognition are unknown. post-operative nutritional deficiencies are common and can adversely impact cognitive performance. however, substantial weight loss resolves or improves many medical conditions with reversible cognitive effects, suggesting bariatric surgery may provide cognitive benefits. no study to date has examined the cognitive effects of bariatric surgery. to do so, the proposed study will prospectively assess cognitive performance in 125 bariatric surgery patients enrolled in the longitudinal assessment of bariatric surgery (labs) project and 125 matched controls. bariatric surgery patients will complete a computerized cognitive test battery at four time points: pre-operatively, 12 weeks post-operatively, 12 months post-operatively, and 24 months post-operatively. matched control participants will complete the test battery at similar intervals. demographic, medical, and psychosocial information will be collected to elucidate possible mechanisms of change. we hypothesize that the substantial weight loss following bariatric surgery will be associated with improved cognitive performance.


Eligibility criteria:
specific criteria for bariatric surgery patients include: inclusion criteria * 25-65 years of age * enrolled in labs project * english-speaking exclusion criteria * history of neurological disorder or injury (e.g. dementia, stroke, seizures) * moderate or severe head injury (defined as \>10 minutes loss of consciousness; alexander, 1995) * past or current history of severe psychiatric illness (e.g. schizophrenia, bipolar disorder) * past or current history of alcohol or drug abuse (defined by dsm-iv criteria) * history of learning disorder or developmental disability (defined by dsm-iv criteria) * impaired sensory function inclusion/exclusion criteria for matched control participants include: * all of the inclusion/exclusion criteria for the surgical patients, except for enrollment in the labs project * no history of bariatric surgery procedures * no interest in bariatric surgery procedures in the next two years

Keywords: bariatric surgery obesity cognitive function
methotrexate in symptomatic knee osteoarthritis

Conditions: Osteoarthritis

Summary: osteoarthritis (oa) is a common disabling condition, for which no effective therapy currently exists.synovitis is commonly demonstrated in knee oa imaging. methotrexate (mtx) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.accordingly,the aim of the present study was to assess the efficacy of mtx in decreasing pain and inflammation.eighty-eight patients with clinical and radiographic criteria of primary knee oa with knee pain, were included in this study.patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral mtx(n=44)or placebo(n=44)for 16 weeks. the primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.there was a statistically significant reduction in pain and improvement in function in the mtx group compared to the placebo group at 16 weeks.


Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis * pain not responding to the usual therapy * synovitis exclusion criteria: * any other inflammatory conditions, * hepatic and renal insufficiency

Keywords: methotrexate knee osteoarthritis synovitis pain reduction function scores
phase 3 evaluation of re-injection of nx-1207 for the treatment of benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hyperplasia

Summary: this study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of nx-1207 given to subjects with benign prostatic hyperplasia (bph) who previously received an injection of nx-1207 in an earlier u.s. clinical trial of nx-1207.


Eligibility criteria:
inclusion criteria: * be male aged 45 or older. * sign an informed consent form. * be in good health. * received nx-1207 in a previous completed study or received nx-1207 or placebo in a concurrent u.s. study (nx02-0017 and nx02-0018) and completed their v10 (365 day) visit. * have prostate gland volume ≥ 25 ml (25 g). exclusion criteria: * surgery or minimally invasive surgical therapy (mist) for treatment of bph after first nx-1207 injection * post-void residual urine volume \> 200 ml * presence of a symptomatic median lobe of the prostate * history of use of self-catheterization for urinary retention. * urinary retention in the previous 12 months. * prostatitis * urinary tract infection more than once in the past 12 months * prostate or bladder cancer. * psa ≥10 ng/ml * poorly controlled diabetes * history or evidence of illness or condition that may interfere with study or endanger subject * participation in a study of any investigational drug (other than nx-1207) or investigational device within the previous 90 days * use of specific prescribed medications that may interfere with study or endanger subject

Keywords: benign prostatic hyperplasia bph enlarged prostate lower urinary tract symptoms luts luts secondary to bph luts/bph benign prostatic obstruction bpo bladder outlet obstruction boo
adsorbtion of cytokines early in septic shock: the acess study

Conditions: Sepsis; Septic Shock

Summary: the aim of the study is to investigate the effect of cytosorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.


Eligibility criteria:
inclusion criteria: * signs of hypoperfusion: serum lactate \>2 mmol/l, low central venous oxygen saturation (scvo2) (\ 85%), metabolic acidosis, oligo-anuria, high venous-to-arterial co2-gap (dco2 \>6 mm hg) * hemodynamic support with vasopressors * procalcitonin level ≥ 3 ng/ml * invasive hemodynamic monitoring * written informed content exclusion criteria: * patients under 18 years * pregnancy (bhcg test positivity) * surgical intervention in context with the septic insult * new york heart association iv heart failure * acute coronary syndrome * need for acute or chronic hemodialysis * acute haematological malignancies * cardiogenic shock * post cardiopulmonary resuscitation care * immunosuppression, systemic steroid therapy (\>10mg prednisolon/day) * human immunodeficiency virus infection (hiv) and active aids * patients with donated organs * thrombocytopenia (\<20.000/ml) * more than 10%-of body surface area with third degree burn

Keywords: hemoadsorption extracorporeal blood purification cytosorb hemofiltration sirs sepsis septic shock membranes icu dialysis adsorption
response of older adults to influenza vaccination with regard to cytomegalovirus (cmv) status

Conditions: Influenza

Summary: the study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their cmv status. cmv is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. their immune system is not working well such as in the case of hiv infection. cmv is believed to have infected up to 80% of individuals in the age group we will be looking at in our study and we are interested in whether this infection affects their responses to vaccination.

human cytomegalovirus (hcmv) is an important pathogen or disease-causing virus, which can result in disease in the unborn child as well as in individuals whose immune systems are not working properly such as those with hiv or who are receiving some treatments for cancer, where the body's ability to fight infection is not as good as in healthy people. hcmv infects the majority of the population, yet rarely causes overt disease which would limit the capacity of the host to transmit hcmv to others. this virus is thought to be millions of years old and because of this we think that it has evolved over time to become very efficient at evading the immune system. this means it has become very efficient at moving through the human population and resulting in humans devoting more immunological resources to controlling this virus than to any other. recent studies have reported that the immune system does work less efficiently in older people, especially in elderly patients with cmv antibodies compared to age matched controls who did not have cmv antibodies. it is well recognized that responses to vaccination are generally lower in older populations compared to children, so they may be thought to be immunologically in a suboptimal position. it is proposed that this may be as a result of diversion of key factors in the immune system to address cmv infection, the incidence of which increases with age. this study will allow assessment of responses to licensed seasonal influenza vaccine with respect to age and cmv status and will provide baseline information as a proof of principle on which a larger study will be designed.

Eligibility criteria:
inclusion criteria: * no contraindications to vaccination as specified in the "green book" - immunisation against infectious disease, hmso. * written informed consent obtained * subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment.

Keywords: influenza vaccine cmv
distribution of smooth muscle in dartos in the non conspicuous penis

Conditions: Congenital Urogenital Anomaly

Summary: non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the appearance of the penis. a redundant and enlarged foreskin is the main feature of this entity.this congenital anomaly is difficult to diagnose and may have association with other pathologies such as buried penis. currently, part of the megaprepuce skin is used to correct the defect. a recent study shows that patients with this pathology and hypospadias present mostly defects in the muscle dartos. the investigators do not know the physiological bases of the megaprepuce, neither the clinical and aesthetics implications of this abnormal tissue for the patient, and how this affects the postoperative evolution. with the present study the investigators intended to answer these questions and to open paths for future research in this area.

after informed consent, patients will be labeled with a research record number other than the identity document or the number of the attention. the urologist who perform the correction of the megaprepuce, will take a segment of the dartos and send it for histopathological analysis: staining with hematoxylin-eosin, smooth muscle actin marker, associated with the research record number. same procedure will be performed with the controls and hypospadias group. only the principal investigator will know the assignment of medical record and their respective group (congenital megaprepuce, hypospadias or controls). the samples will be sent to pathology without any clinical data, and they will be analyzed by two pathologists, both blind.

Eligibility criteria:
inclusion criteria: * male patients scheduled for correction of congenital megaprepuce * male patients scheduled for correction of hypospadias * male patients scheduled for circumcision for non-medical reasons. exclusion criteria: * patients with a history of hypospadias correction.

Keywords: congenital abnormalities hypospadias congenital megaprepuce histology
a pilot clinical trial of tena identifi in the nursing home setting

Conditions: Urinary Incontinence

Summary: the purpose of this study is to prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the tena identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy, nursing effort, product use, and wet-time for urinary incontinence.

urinary incontinence in nursing homes influences resident dignity and quality of life. it also drives significant use of healthcare resources, including time and caregiver assistance, and costs of care. various toileting programs are used to address urinary incontinence, including habit training, bladder training, prompted voiding, and check and change procedures. clinical trials have found that 33% to 60% of residents either became continent or reduced the frequency of incontinence episodes to less than one per day with the introduction of a prompted voiding program. there are several drawbacks to current programs. manually recorded wet checks do not identify when incontinence occurs, only when wetness is detected, reducing the precision of time of incontinence to the window of time between checks. nursing home staff create individualized care plans for each resident, based on standard check and change procedures, but poor precision in ascertaining timing and quantity of incontinence episodes can contribute to less frequent resident toileting or changing.

Eligibility criteria:
inclusion criteria: 1. males or females 55 years of age or older with stable clinical status 2. long-stay status (more than 90 days) 3. ambulatory and able to use a toilet either independently or with assistance 4. minimum data set (mds) level 1 (occasionally), 2 (frequently) or 3 (always) rating of incontinence 5. currently wearing disposable briefs for urinary incontinence exclusion criteria: 1. chronically bed-bound (mds g0110a rating 8) 2. mds self-performance rating of 4 (total dependence) for toilet use 3. fecal incontinence (mds h0400 rating 0) 4. use of urinary appliance such as catheters or ostomies (mds h0100 z) 5. private duty nurse care 6. residents who tear at clothing or disposable undergarments 7. current urinary tract infection receiving treatment 8. current diarrhea receiving treatment 9. residents who are not likely to benefit from a toileting plan based on assessment of nursing staff

Keywords: urinary incontinence, nursing home
evaluation of the follow me mode of the autolap system - a feasibility study

Conditions: Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

Summary: the main objectives of this study are to evaluate the performance and ease of use of the follow me mode of the autolap system during general and gynecological laparoscopic procedures.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form (icf). 2. patients over 18 years exclusion criteria: 1. pregnancy 2. extensive adhesions that will preclude routine laparoscopic surgical approach. 3. american society of anesthesiologists' (asa) classification\>2

Keywords: laparoscopic cholecystectomy laparoscope holder gynecological laparoscopy procedures fundoplication surgery laparoscopic adnexal surgery excision of endometriosis lesion diagnostic laparoscopy procedures right hemicolectomy diaphragmatic hernia
gip, glp-1 and glp-2 in type 2 diabetic hyperglucagonemia

Conditions: Type 2 Diabetes Mellitus

Summary: in order to investigate the mechanisms underlying the hyperglucagonemia characterizing patients with type 2 diabetes mellitus (t2dm) we wish to test the following hypothesis: do pancreatic alpha-cells exhibit inappropriate glucagon responses to substances released from the small intestine (gip, glp-2 and glp-2) in patients with t2dm?

patients with t2dm are not able to suppress their secretion of glucagon after a meal or after oral ingestion of glucose. patients actually respond with pathological high plasmaglucagon concentrations to these stimuli. previous studies have shown that postprandial hyperglucagonemia results in increased hepatic glucose production and therefore contributes significantly to the hyperglycemia characterizing these patients. recently we have shown that patients with t2dm exhibit a normal suppression of glucagon secretion following an adjustable intravenous (iv) glucose challenge mimicking the glucose excursion following a 50-g oral glucose tolerance test (ogtt) with the latter resulting in lack of glucagon suppression. why this difference? a possible explanation could be that the oral administration stimulates intestinal factors resulting in a differentially glucagon response to the two similar glucose excursions. we wish to establish whether gip, glp-1 and/or glp-2 are responsible for the inappropriate glucagon suppression following ogtt and meals in patients with t2dm.

Eligibility criteria:
inclusion criteria: * caucasians with diet and/or tablet treated t2dm of at least 3 months duration (diagnosed according to the criterias of the world health organization (who)) * normal hemoglobin * prior informed consent exclusion criteria: * liver disease (alat/asat \> 2 x upper normal value) * diabetic nephropathy (se-creatinin \> 130 um and/or albuminuria * treatment with drugs that cannot be discontinued for 12 hours

Keywords: diabetes mellitus glucagon insulin incretin hormones glucose-dependent insulinotropic polypeptide glucagon-like peptide-1 glucagon-like peptide-2
early warning value of consumer wearable devices in aecopd

Conditions: COPD

Summary: this is a prospective, multi-center cohort study. 150 subjects with copd and in stable stage will be included. wearable device's physiological parameters will be continually collected, the investigators aim to explore whether consumer wearable devices are useful for early warning deterioration of copd.

this is a prospective cohort study. 150 subjects aged 35～80y with stable copd will be recruited. after enrollment, subjects wear consumer wearable devices and install app on their mobile phones. the first 7 days of wearing are to evaluate the stability of data collection and the subject compliance, and to correct the wrong wearing. the subjects are required to fill in the copd symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. the physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. the department of respiratory and critical care of peking university first hospital is responsible for this research. primary outcome is the moderate or more severe copd acute exacerbation events. the purpose of this study is to use consumer wearable devices to monitor the changes of copd, and to establish a physiological parameters model of wearable device that can predict the acute exacerbation of copd. the study protocol has been approved by the peking university first hospital institutional review board (irb) (2021-397). any protocol modifications will be submitted for the irb review and approval.

Eligibility criteria:
inclusion criteria: * patients diagnosed with stable copd (refer to 2021 gold guidelines); * age between 35 and 80 years (both 35 and 80), either gender; * a post-bronchodilator forced expiratory volume in 1 second percentage (fev1%) predicted between 25%\~80%; * having mobile phone which can install app of wearable device; * able to engage in daily activities; exclusion criteria: * history of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease; * history of lobectomy and/or lung transplantation; * predicted life expectancy less than 3 years; * history of serious underlying diseases (including severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease); * alcoholism, drug or toxic solvents abuse; * moderate to severe anemia; * smoking or quitting smoking for less than 6 weeks; * skin pigmentation, deformity, arterial stenosis or occlusion of both upper limbs; * skin allergy to metal/plastic; * those who are participating in other clinical trials, cannot be followed up for a long time or have poor compliance.

Keywords: copd aecopd consumer wearable device